eBook: Analyzing Critical Quality Attributes for Efficient and Rapid Cell Line Development

Last updated: June 2023


Cell line development (CLD) is the engineering of a cell line, often mammalian, to produce a therapeutic biomolecule or biologic. It allows scientists to tailor cultures depending on the applications and desired properties of the targeted product. A typical CLD process revolves around five key stages.

The process includes the screening of thousands of clones to find those that are stable, produce high yields of the bioproduct and exhibit desired critical quality attributes (CQAs). During the process, cells must be monitored for viability, morphology, density and monoclonality. In addition, product-related attributes such as titer, glycosylation levels, propensity to aggregate and ability to bind to target need to be monitored early in the process to minimize product failure down-stream.

Due to the high number of clones screened upstream, analytics that enable high-throughput screening at the various stages of the process are desirable. In this eBook, we describe how Sartorius’ analytical technologies fulfill critical needs along the entire span of the CLD workflow.

  • Document type: eBook
  • Page count: 25
  • Read time: 31 minutes

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Key Takeaways

  • Key stages in the CLD workflow
  • The benefits of leveraging high-throughput nanowell-based image-verified cloning technology for CLD
  • Methods for accurately tracking cell count and viability
  • Techniques for rapidly assessing and selecting clones
  • Integrating bioanalytical platforms to optimize cell culture conditions
  • Bioassays for functional characterization

A typical CLD process revolves around five key stages:

cell line development workflow

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